Quality Associate

Posted 4 Days Ago
Be an Early Applicant
Seoul, KOR
In-Office
Mid level
Healthtech
The Role
Manage pharmaceutical quality activities including technical complaints, deviations, change controls, CAPAs, analytical method validation and transfers, product release support, quality documentation, GMP training, audits, inspections, and health-authority requests. Maintain quality agreements with manufacturing sites and suppliers, track corrective actions, and provide backup support for Annual Product Quality Review activities.
Summary Generated by Built In

Job title: Quality Associate

 

●         Location: Seoul, South Korea
* This is a 1.5 year temporary position.


About the job


About Sanofi:


We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.


Main responsibilities:


  • Manage product technical complaints, monitor investigation activities, and follow up on outcomes to ensure timely resolution.
  • Handle quality events, including deviations, change controls, and CAPA activities.
  • Coordinate and support analytical method validation and transfer activities to ensure timely and successful implementation.
  • Maintain quality agreements with manufacturing sites and third-party suppliers of products and reference standards.
  • Support product release activities in compliance with local regulatory requirements and company quality standards.
  • Maintain quality documentation and training records, ensuring they remain accurate and up to date.
  • Support the delivery and tracking of GMP and quality-related training activities across the team.
  • Support quality audits and inspections, including self-inspections, MFDS overseas GMP inspections, MFDS GIP inspections, and health authority inspections.
  • Follow up on inspection observations and corrective and preventive actions (CAPAs) to ensure timely closure.
  • Liaise with local health authorities regarding quality-related regulatory requests and commitments.
  • Serve as backup for Annual Product Quality Review (APQR) activities.

About you


  • Experience: Background in pharmaceutical quality assurance, quality control, or regulatory affairs(2-5 years of relevant experience required)
  • Soft and technical skills: Strong attention to detail, analytical thinking, and familiarity with GxP quality systems and complaint/deviation handling processes; able to work independently and collaboratively across cross-functional teams
  • Education: Degree in Pharmacy, Chemistry, Life Sciences, or a related field
  • Languages: Professional proficiency in English for collaboration with global teams

Why choose us?


  • Help shape the future of care for chronic and complex conditions like aT1D, Type 2 diabetes, transplant, and cardiovascular disease.
  • Drive meaningful impact at global scale: our medicines reach more than 100 million people each year.
  • Be part of a simpler, digital- and AI-powered business that’s rethinking how we work and engage with the world.
  • Turn bold ideas into breakthrough launches, with multiple new therapies planned through 2030 and beyond.
  • Stretch your career in a development playground, with opportunities across functions, regions, and the entire product lifecycle.

Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

Skills Required

  • 2–5 years of relevant experience in pharmaceutical quality assurance, quality control, or regulatory affairs
  • Degree in Pharmacy, Chemistry, Life Sciences, or a related field
  • Familiarity with GxP quality systems and complaint/deviation handling processes
  • Professional proficiency in English
  • Strong attention to detail and analytical thinking
  • Ability to work independently and collaboratively across cross-functional teams

Sanofi Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Sanofi and has not been reviewed or approved by Sanofi.

  • Retirement Support — Retirement support stands out through a notably strong 401K matching structure (e.g., 150% match up to a 6% contribution), which materially boosts total rewards for long-tenured employees.
  • Parental & Family Support — Parental and family support is positioned as unusually robust, including a global gender-neutral paid parental leave standard (14 weeks) and added supports such as childcare assistance and adoption/surrogacy/infertility help.
  • Equity Value & Accessibility — Equity participation is made more accessible via an Employee Stock Purchase Plan that includes a meaningful purchase discount and matching/free-share mechanics, increasing perceived total compensation beyond base pay.

Sanofi Insights

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The Company
HQ: Paris
85,000 Employees
Year Founded: 1973

What We Do

We are Sanofi, an innovative global healthcare company. We chase the miracles of science to improve people’s lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Interactions with this account must comply with the Terms: https://bit.ly/sanofi-terms

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